None listed
Conditions
Interventions
Group 1 Type of group
MK-0518 of 400 mg PO b.i.d. + placebo corresponding to KALETRA PO b.i.d. + antiretroviral therapy in the background
Group name:Group 2 Type of group
KALETRA 400/100 mg PO b.i.d. + placebo corresponding to MK-0518 PO b.i.d. + antiretroviral therapy in the background
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • The patient is a man or woman of at least 18 years of age on the day of signing the informed consent. • The patient is HIV positive according to the determination of the enzyme-linked immunosorbent assay (ELISA) or the HIV RNA of the documented medical history. • The patient has a POR of the RNA of! Documented HIV 50 copies / mL during this time. • The patient has no history of coronary artery disease. • The patient has the following laboratory values ​​within 35 days prior to the treatment phase of this study: Alkaline Phosphatase <5.0 x normal upper limit, AST (SGOT) and ALT (SGPT) <5.0 x normal upper limit. Patients with a chronic coinfection of Hepatitis B and / or C can be enrolled as long as patients are stable and meet all eligibility criteria. • The patient does not present clinical evidence of active lung disease; A chest x-ray may be obtained if deemed necessary by the investigator. • The patient is potentially fertile and agrees to use an acceptable method of contraception throughout the study. An acceptable method of contraception is defined as intrauterine device (IUD), diaphragm with spermicide, condoms or abstinence. Oral contraceptives are not recommended in this study because contraceptive steroid concentrations may be altered when KALETRA is coadministered with oral contraceptives or contraceptive patches or the patient who is not potentially fertile is not sexually active, whose ( s) current partner (s) are not / are potentially fertile, or whose sexual activity is exclusively homosexual is eligible without the use of contraceptive methods. • The patient agrees not to take the concomitant prohibited drugs as described in Section 3.2.1 of the protocol.
Exclusion criteria
Exclusion criteria: • The patient is receiving a regimen based on KALETRA ™ that includes Stavudine (d4T) as a component of background antiretroviral therapy. • The patient is receiving a regimen based on KALETRA ™ that includes a second protease inhibitor in addition to KALETRA. • The patient is currently receiving, or has received in the last twelve weeks, agents known to have an effect on lipid levels (eg, fish oils, lipidol, bile acid sequestrants, HMG-CoA reductase inhibitors) [such as simvastatin, atorvastatin, rosuvastatin], ezetimibe, ezetimibe / simvastatin, fibrates, niacin, plant sterols, and / or red yeast). • The patient has a medical history that includes diabetes mellitus. • The patient has a current history or evidence of any condition, therapy, laboratory abnormality or other circumstance that could confuse the results of the study, or interfere with the patient´s participation throughout the study, so that the patient does not feel the best interest to participate. • The patient has a history of alcoholism or abuse of other substances that, in the opinion of the investigator, could interfere with the patient´s compliance or safety. • The patient is currently participating or has participated in a study with a compound or device under investigation within 30 days of signing the informed consent. • The patient has ever used any experimental inhibitor of HIV integrase. • The patient has used a systemic immunosuppressive therapy (eg, 20 mg or more of prednisone or equivalent per day) within one month before treatment in this study. Short courses of corticosteroids will be allowed (for example, for the exacerbation of asthma). • The patient requires hemodialysis. • The patient has significant hypersensitivity or another contraindication to any of the components of the study drugs. • The patient has chronic hepatitis, with evidence of unstable liver function. This includes patients who, in the opinion of the investigator, present evidence of synthetic liver dysfunction, such as hypoalbuminemia or prolonged PT and PTT. • The patient is pregnant or breastfeeding, or expects to conceive (within the duration of the study). The patient is estimating to donate ovules (within the duration of the study). The patient is estimating to donate sperm (within the duration of the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Using the Ultrasensitive AMPLICOR HIV-1 Monitor (version 1.5). It is expected that a high percentage of patients will maintain HIV RNA levels below the reliable quantification limit (LoQ) of 50 copies / mL for the Ultrasensitive AMPLICOR HlV-1 Monitor (version 1.5) throughout the study. Measure:Proportion of patients with plasma HIV RNA <50 copies / mL in Week 24 Timepoints:Week 24 ; Outcome name:The levels of LDL-C, HDL-C, non-HDL-C, total cholesterol and triglycerides will be measured at specific evaluation points. The percentage change with respect to the baseline in these lipids will be summarized by treatment group in each available evaluation point, with primary emphasis in Week 12. Measure:Average percentage changes with respect to the baseline in total cholesterol, triglycerides, non-HDL-C and LDL-C in Week 12 Timepoints:Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The changes with respect to the baseline in the CD4 cell count per treatment group will be summarized in each evaluation point Measure:Change from baseline in CD4 cell counts in Week 48 Timepoints:Week 48 ; Outcome name:The levels of LDL-C, HDL-C, non-HDL-C, total cholesterol and triglycerides will be measured at specific evaluation points. The percentage change with respect to the baseline in these lipids per treatment group will be summarized in each available evaluation point Measure:Average percentage changes in triglycerides, not HDL-C and LDL-C with respect to total basal cholesterol in Week 24 and Week 48 Timepoints:Week 24 and Week 48 ; Outcome name:Using the Ultrasensitive AMPLICOR HIV-1 Monitor (version 1.5). It is expected that a high percentage of patients will maintain HIV RNA levels below the reliable quantification limit (LoQ) of 50 copies / mL for the Ultrasensitive AMPLICOR HlV-1 Monitor (version 1.5) throughout the study. Measure:Proportion of patients with HIV RNA <50 copies / mL in Week 48 Timepoints:Week 48 ; Outcome name:The changes with respect to the baseline in the CD4 cell count per treatment group will be summarized in each evaluation point Measure:Change from baseline in CD4 cell counts in Week 24 Timepoints:Week 24 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed